Navigation Links
Doctors Can Use Rotavirus Vaccine Again: FDA

Contaminant found in March no health risk, agency says

FRIDAY, May 14 (HealthDay News) -- Doctors can resume using the vaccine Rotarix to prevent rotavirus, a common cause of severe diarrhea in children, the U.S. Food and Drug Administration said Friday.

On March 22, the FDA recommended that doctors temporarily stop using the oral vaccine -- one of two brands available to prevent rotavirus -- because doses appeared to be contaminated with a benign pig virus.

The FDA said it wanted to identify the source of the contamination and make certain that any potential harm from contamination had been identified. The pig virus -- known as porcine circovirus 1 (PCV1) -- isn't known to cause illness in humans, FDA Commissioner Dr. Margaret Hamburg said at the time.

In a statement released Friday, the FDA said it had determined that "it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq," a second rotavirus vaccine.

The agency said it based its decision on an evaluation of information from laboratory results from the manufacturer (Rotarix is made by GlaxoSmithKline) and the FDA's own laboratories, as well as a review of the scientific literature and advice from scientific and public health experts.

In reaching its decision, the FDA cited both vaccines' safety records, which include clinical trials involving tens of thousands of patients as well as the experience of millions of vaccine recipients.

The agency said there's no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.

The FDA also pointed to the vaccines' benefits, which it called "substantial."

According to the U.S. Centers for Disease Control and Prevention, rotavirus causes vomiting, fever and dehydration and is the leading cause of diarrhea in infants and young children. Almost all children in the United States are likely to be infected before they turn 5 years old.

Treatment includes replacing lost body fluids with drinkable products with water, sugar and minerals, the CDC advises.

More information

For more on rotavirus and the vaccines, visit the FDA.

-- HealthDay staff

SOURCES: May 14, 2010, news release, U.S. Food and Drug Administration

Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Interruptions Make Doctors Lose Track of Tasks
2. Traffic Logix Solutions Protect Doctors and Patients at Northeastern Hospitals
3. Barbara Walters Prognosis Is Excellent, Doctors Say
4. Doctors use ultrasound to diagnose possible muscular trauma in professional athletes on-site
5. Harvard Health Letter Features Q&As from Harvard Doctors
6. Mom-Doctors: How they Balance Home and Career
7. Strategy to help doctors determine when to treat retinopathy of prematurity
8. AngioDynamics' VenaCure EVLTTM System for Varicose Veins To Be Featured On 'The Doctors' National Television Program
9. Announces Weed Team Contest Winner, Adds Additional Trip to the Cannabis Cup in Amsterdam
10. National Allergy Supply, The Allergy Products Company Recommended By More Than 9,500 Doctors Nationwide, Announces 100% Unconditional Satisfaction Guarantee
11. HCL Thames Medics says more locum doctors could help address European Working Time Directive shortage
Post Your Comments:
(Date:11/29/2015)... ... ... Key Housing, a top-rated corporate housing service for the San Jose and ... In showcasing this featured apartment community in San Jose, Key Housing is helping those ... find housing suitable to their needs by showcasing quality housing. , “San Jose many ...
(Date:11/28/2015)... ... ... November 30th at 6:00 a.m. EST until 11:59 p.m. EST, customers will ... to 20% off orders $80 or more to free gifts with purchases, there will be ... a competitive e-commerce website for skin care and cosmetic needs, customers will save on already ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... According ... carried out by the University of Toronto and the University of British Columbia suggested ... hospitalizations for head injuries. The article explains that part of the reason for the ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, from ... dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. , ... prescription medications. In doing so, it could help to prevent potential overdose situations. ...
(Date:11/27/2015)... Viejo, CA (PRWEB) , ... November 27, 2015 , ... ... for use in Final Cut Pro X. With ProSidebar: Fasion, video editors can ... or use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating drop ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Competitive Intelligence, ... --> ) has ... Future Horizons and Growth Strategies in ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the European Therapeutic Drug Monitoring (TDM) ... Competitive Intelligence, Emerging Opportunities"  report to ... ) has announced the addition of ...
(Date:11/26/2015)... ) has ... Market by Type (Reagents & Kits, Analyzers), ... Diagnostic Labs), Application (Research, Clinical Diagnostics), and ... report to their offering. --> ... the "Radioimmunoassay Market by Type (Reagents ...
Breaking Medicine Technology: